Knee Device Maker Blasts FDA for Approval Reversal

We just wrote that the US Food and Drug Administration (FDA) announced that ReGen Biologicâ€™s Menaflex Collagen Scaffold, an orthopedic device used in the knee, should not have been cleared for marketing in the United States. Now, says NJ.com, ReGen Biologics is criticizing the FDA for revoking its approvalâ€”for the past two yearsâ€”of its top-selling device.

The Menaflex Collagen Scaffold was cleared for marketing by the FDA in December 2008 for the repair and reinforcement of the kneeâ€™s meniscus tissue, the meniscus is a C-shaped disk of fibrocartilage that cushions the ends of bones in the joint and helps lubricate the joint.

The device was approved through a process known as 510(K), which doesnâ€™t require human clinical trials and is meant for devices substantially similar to products already on the marketâ€”so-called predicate devices. As weâ€™ve reported previously, ReGenâ€™s 510(K) application for Menaflex was rejected by FDA scientists on three occasions, with the agencyâ€™s staff asserting it wasnâ€™t eligible for the process. But, agency managers ultimately overruled the scientists and approved Menaflex in December 2008.

A September 2009 report recommended a scientific re-evaluation because the administrative record did not supply a basis for the FDAâ€™s December 2008 decision that was adequate to dispel questions about the role of outside pressures on the review process. This re-evaluation, initiated in the fall of 2009, included a team of scientists at the agency not involved in previous reviews. Another advisory committee meeting was also held in March 2010.

The FDA concluded that the Menaflex device is meant for different purposes and is technologically dissimilar from predicate devices. These differences can affect the safety and efficacy of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace surgically removed tissue. Because of these differences, the Menaflex device should not have been cleared by the agency.

On Monday, Gerald Bisbee, Menaflexâ€™s chief officer, said the agencyâ€™s decision was politically based, “The agencyâ€™s clearance of Menaflex has become a political football and the FDA is not playing by the rules,” Bisbee said in a statement, quoted NJ.com

“ReGen has invested 58 months and more than $30 million to meet (the centerâ€™s) requirements,” Bisbee stated, “only to have the agency reverse decisions made by previous officials by stating that they were in error with no substantial evidence that is true,” Bisbee added, according to NJ.com.

We previously wrote that a report issued by the FDAâ€™s Center for Devices last fall found that agency officials repeatedly deviated from procedures in approving Menaflex. According to the report, the FDAâ€™s Congressional Liaison said the political pressure put on the agency was â€œthe most extreme he had seen, and the agencyâ€™s acquiescence to the companyâ€™s demands for access to the commissioner and other officials in the commissionerâ€™s office as unprecedented.â€ The document also criticized former FDA Commissioner Andrew von Eschenbach for pressuring other FDA officials to act quickly.